As the first transcatheter heart valve to receive FDA approval, the MELODY transcatheter pulmonary valve therapy offers valve replacement without open surgery. FDA granted approval to the device in 2010 through its Humanitarian Device Exemption program; it has had CE Mark since 2006. Patients often suffer from congenital heart disease they have had since they were born, so minimally invasive options to treat lifelong pulmonary valve dysfunction are important.

MELODY was awarded the Prix Galien award for "Best Medical Technology" in 2012, a title it shared with Edwards Lifesciences' Sapien transcatheter aortic valve that year. 

Learn about "How to Set Your Connected Health Solution Apart" at BIOMEDevice San Jose, December 7-8.